WO2022237836A1 - Dispositif de protection embolique - Google Patents

Dispositif de protection embolique Download PDF

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Publication number
WO2022237836A1
WO2022237836A1 PCT/CN2022/092218 CN2022092218W WO2022237836A1 WO 2022237836 A1 WO2022237836 A1 WO 2022237836A1 CN 2022092218 W CN2022092218 W CN 2022092218W WO 2022237836 A1 WO2022237836 A1 WO 2022237836A1
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WO
WIPO (PCT)
Prior art keywords
embolic protection
protection device
frame
head
distal end
Prior art date
Application number
PCT/CN2022/092218
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English (en)
Chinese (zh)
Inventor
刘建勇
李安宁
葛洋
朱万诚
汤麟
Original Assignee
深圳市先健呼吸科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 深圳市先健呼吸科技有限公司 filed Critical 深圳市先健呼吸科技有限公司
Priority to EP22806798.9A priority Critical patent/EP4338704A1/fr
Priority to CN202280003954.0A priority patent/CN115916111A/zh
Publication of WO2022237836A1 publication Critical patent/WO2022237836A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/013—Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/016—Filters implantable into blood vessels made from wire-like elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/018—Filters implantable into blood vessels made from tubes or sheets of material, e.g. by etching or laser-cutting

Definitions

  • the invention relates to the technical field of interventional medical devices, in particular to an embolism protection device.
  • Cerebral embolism refers to various emboli in the blood (such as wall thrombus in the heart, atherosclerotic plaque, fat, tumor cells, fibrocartilage or air, etc.) entering the relatively narrow and curved cerebral arteries along with the blood flow.
  • emboli such as wall thrombus in the heart, atherosclerotic plaque, fat, tumor cells, fibrocartilage or air, etc.
  • Cerebral embolism often occurs in the internal carotid artery system, and the vertebral-basilar artery system is relatively rare. Cerebral embolism accounts for about 15% to 20% of ischemic strokes. About 75% of cardiogenic emboli embolize in the brain.
  • valve replacement is mainly transcatheter aortic valve implantation (Transcatheter Aortic Valve Implantation, TAVI), through the femoral artery into the interventional catheter, the artificial heart valve is delivered to the aortic valve area to open, so as to complete the artificial valve implantation, restore valve function.
  • TAVI Transcatheter Aortic Valve Implantation
  • the three branches of the aortic arch need to effectively filter emboli in order to minimize the risk of stroke.
  • Most of the existing anti-embolism protection devices are nickel-titanium alloy frame plus filter membrane structure to block the three branches of the aortic arch.
  • the filter membrane usually needs to be supported by a sheath core bent at the arch.
  • embolic protection device which usually uses a cut and pre-bent support net to fit the inner walls of the three branches to achieve filtration.
  • the filter membrane or filter mesh cannot fit the aortic arch walls at the three branches well, resulting in some emboli still entering the aortic arch branches, which poses a safety hazard.
  • An embolic protection device comprising a frame and a filter screen covering the frame, the embolic protection device also includes a plurality of support rods arranged at intervals along its axial direction, the support rods include a first end, a second end and at least one head end facing the distal end, the first end and the second end are respectively connected to opposite sides of the frame, and a first line segment is formed between the first end and the head end , a second line segment is formed between the second end and the head end, the first line segment extends from the first end toward the head end and gradually moves away from the frame, the second line segment extends from The second end extends toward the head end and gradually moves away from the frame, so that the plurality of support rods directs the filter net covered on the plurality of support rods in a direction away from the frame hold up.
  • the value range of the vertical distance from the highest point on the support rod to the horizontal plane is greater than or equal to 0 mm and less than or equal to 30 mm.
  • the vertical distance from the head end to the vertical projection point of the horizontal plane to the line connecting each of the first end and the second end to the vertical projection point of the horizontal plane is greater than or equal to 20 mm and less than or equal to 120 mm.
  • the shortest distance between the first end and the second end ranges from 20 mm to 100 mm.
  • At least one of the head ends bends and extends toward the distal end and toward the frame.
  • At least one of the head ends is provided with an anti-damage piece.
  • At least one sliding constraint ring is provided on the embolic protection device.
  • the sliding constraint ring is arranged on the frame of the embolic protection device, or on at least one head end of at least one support rod.
  • the proximal end and/or the distal end of the embolic protection device is provided with at least one developing member.
  • the embolic protection device further includes a connecting piece connected to the proximal end of the frame.
  • the connecting member is rotatably connected with the frame.
  • the proximal end of the frame is provided with at least one connecting hole, and the distal end of the connecting piece passes through the connecting hole and is fixed on the connecting piece, so that the connecting piece is connected to the connecting piece.
  • the above-mentioned frame is rotated and connected.
  • the connecting member is connected to the frame through a universal ball device.
  • the connecting member is connected to the frame through a hinge device.
  • An embolic protection system comprising an elongated sheath core and any one of the above embolic protection devices.
  • At least one sliding confinement ring is provided on the embolic protection device, one end of the embolic protection device is fixed on the sheath core, and the other end can pass through the sliding confinement ring along the sheath core. Perform axial movement.
  • the embolic protection device includes a plurality of support rods arranged at intervals along its axial direction, and since the first end and the second end of the support rods are respectively connected to opposite sides of the frame, And the first line segment formed from the first end to the head end on the support rod, and the second line segment formed from the second end to the head end respectively extend from the corresponding end toward the head end and gradually move away from the frame.
  • the structural design makes the support rods extend upward toward the far end and away from the frame, and the head ends of the support rods are suspended, so that the filter screens covered on these support rods can be lifted upward toward the direction away from the frame.
  • the filter can be attached to the three branches of the aortic arch, and in practical applications, the frame and the support rods can interact and promote each other, which can not only make the frame more stable at the aortic arch, but also Each support rod can be promoted to give the filter screen a greater upward support force, thereby promoting the filter screen to better fit the upper wall tissue of the aortic arch.
  • FIG. 1 is a schematic diagram of the overall structure of the embolic protection device of Embodiment 1;
  • Fig. 2 is a schematic structural view of the embolic protection device in Fig. 1 when the filter screen is not covered;
  • Fig. 3 is a top view of the structure shown in Fig. 2;
  • Fig. 4 is another schematic structural view of the embolic protection device of embodiment 1 when the filter screen is not covered;
  • Figure 5 is a top view of the structure shown in Figure 4.
  • Fig. 6 is another schematic structural view of the embolic protection device of embodiment 1 when the filter screen is not covered;
  • Fig. 7 is a structural schematic diagram when the structure shown in Fig. 2 is placed on a horizontal plane;
  • Fig. 8 is a schematic diagram of implanting the embolic protection device in Fig. 1 into the aortic arch;
  • Example 9 is a schematic diagram of the overall structure of the embolic protection device of Example 2.
  • Fig. 10 is a schematic structural view of the embolic protection device in Fig. 9 when the filter screen is not covered;
  • Fig. 11 is another structural schematic diagram of the embolic protection device of Example 2.
  • Fig. 12 is a schematic structural view of the embolic protection device of Fig. 9 when it is accommodated in the sheath;
  • Fig. 13 is a schematic diagram of the embolic protection device of Fig. 9 being implanted in the aortic arch;
  • Fig. 14 is a schematic diagram of the overall structure of the embolic protection device of Example 3.
  • Figure 15 is an enlarged schematic view of E in Figure 14;
  • Fig. 16 is another schematic structural view of the embolic protection device of Example 3.
  • Figure 17 is an enlarged schematic view of F in Figure 16;
  • Fig. 18 is another schematic structural view of the embolic protection device of Example 3.
  • Figure 19 is an enlarged schematic view of G in Figure 18;
  • Fig. 20 is another structural schematic diagram of the embolic protection device of Example 3.
  • Figure 21 is an enlarged schematic view of K in Figure 20;
  • Fig. 22 is a schematic diagram of the overall structure of the embolic protection device of Example 4.
  • Figure 23 is an enlarged schematic view of J in Figure 21;
  • Figure 24 is a cross-sectional view of the universal ball device of the embolic protection device.
  • Fig. 25 is a schematic diagram of the overall structure of the embolic protection device of Example 5.
  • FIG. 26 is an enlarged schematic view of S in FIG. 25 .
  • proximal end the end of a medical device implanted in a human or animal body that is closer to the operator
  • distal end the end that is farther from the operator
  • proximal end the end of a medical device implanted in a human or animal body that is closer to the operator
  • distal end the end that is farther from the operator
  • proximal end the end of a medical device implanted in a human or animal body that is closer to the operator
  • distal end the end that is farther from the operator
  • distal end the end that is farther from the operator
  • proximal end the end that is farther from the operator
  • distal end the end that is farther from the operator
  • Embodiment 1 proposes an embolic protection device, which is used in valve replacement surgery as an example, to prevent particles such as thrombus or hard lumps in the blood flow from flowing into the brain through any of the three branches of the aortic arch at the position of the aortic arch. lead to cerebral embolism.
  • it can also be used in thoracotomy to filter blood, or implanted in blood vessels to filter particles or particles such as thrombus or calcification.
  • the embolic protection device 100 includes a frame 110 and a filter 120 covering the frame 110 , and also includes four support rods 130 arranged at intervals along the axial direction of the embolic protection device 100 .
  • Each support rod 130 is V-shaped and includes a first end 131, a second end 131 and a distal end 132, the first end 131 and the second end 131 are respectively fixedly connected to opposite sides of the frame 110 .
  • a virtual first line segment V1 is formed between the first end 131 and the head end 132
  • a virtual second line segment V2 is formed between the second end 131 and the head end 132
  • the first line segment V1 is from the first end 131 toward the head end.
  • the second line segment V2 extends from the second end 131 toward the head end 132 and gradually away from the frame 110, that is, at least a part of each support rod 130 is from its corresponding first
  • the end 131 and the second end 131 respectively extend toward the corresponding head end 132 and gradually move away from the frame 110 , so as to prop up the filter screen 120 covering the four supporting rods 130 toward the direction away from the frame 110 .
  • a part of the support rods 130 can be selected for propping up the filter screen 120 away from the frame 110 , and another part of the support rods 130 can have other shapes and other functions.
  • the frame 110 is a closed frame in the embolic protection device 100 .
  • the shape of the frame 110 is similar to an ellipse or a leaf shape with a hollow inside.
  • the frame 110 can be made of alloys or polymer materials with shape memory properties, such as nickel-titanium alloys, cobalt-chromium alloys, TPU (Thermoplastic polyurethanes, thermoplastic polyurethane elastomer rubber), PTFE (Poly tetrafluoroethylene, polytetrafluoroethylene), PE (polyethylene, polyethylene), etc.
  • the surface enclosed by the frame 110 may be parallel to the horizontal plane, or be an arcuate surface conforming to the shape of the aortic arch.
  • the filter screen 120 is a film made of polymer materials such as PTFE, TPU or PET (Polyethylene terephthalate, polyethylene terephthalate), and can also be made of braided wire with shape memory characteristics through weaving.
  • the thickness of the filter screen 120 ranges from 10 microns to 55 microns, and there are many small holes 121 for filtering on the membrane.
  • the diameters of the small holes 121 range from 25 microns to 300 microns.
  • the shape and size of the filter 120 are similar to or match those of the frame 110 , as long as the filter 120 can completely cover the frame 110 and the edge of the filter 120 can be fixedly connected to the frame 110 .
  • the edge portion of the filter screen 120 is fixedly connected to the frame 110 by glue, high frequency, laser welding, sewing and other processes.
  • the filter screen 120 can filter large particles such as larger thrombi or hard clots, and can also filter particles such as small blood clots or small hard clots.
  • the supporting rod 130 can be made of the same material as the frame 110 .
  • the supporting rod 130 can be made separately and then fixed on the frame 110 , or can be made of the same sheet material as the frame 110 after being cut and heat-set.
  • the minimum distance between the head ends 132 of two adjacent support rods 130 ranges from 5 mm to 100 mm.
  • the first end 131 and the second end 131 on the same support rod 130 can be symmetrical along the central axis of the frame 110, which can not only promote the frame 110 to have greater radial support and anchoring stability, but also make the filter screen 120 Maximum fit on the superior wall of the aortic arch.
  • the first end 131 and the second end 131 of the same support rod 130 may also be asymmetrical along the central axis of the frame 110 .
  • the head end 132 of the support rod 130 is away from the frame 110 and suspended in the air, the first part of the support rod 130 from its first end 131 to its head end 132 and the second part from its second end 131 to its head end 132, gradually
  • the filter mesh 120 covered on the support rod 130 is propped up toward the direction away from the frame 110 , so that this part of the filter mesh 120 can stably attach to the upper wall of the aortic arch without using the sheath core to prop it up.
  • the number of support rods 130 may also be 3 or 5, and an appropriate number of support rods 130 may be provided as required.
  • the angle a between the two struts 133 constituting a V-shaped bar 130 ranges from 10 degrees to 145 degrees.
  • the included angle a is less than 10 degrees, when the embolic protection device 100 is unsheathed, the support rod 130 cannot provide sufficient stretching force for the frame 110 , and the frame 110 may not be well anchored on the inner wall of the aortic arch.
  • the included angle a is greater than 145 degrees, the embolic protection device 100 is less flexible in the radial direction and may damage blood vessels.
  • the value of the included angle a between the two struts 133 of the support rod 130 is 135 degrees.
  • the support bar 130 can also be a U-shaped bar; or, the support bar 130 can be composed of two or more V-shaped bars and/or U-shaped bars connected in series, as shown in Figure 4 and Figure 5
  • the W-shaped bar 130 made of two V-shaped bars can also be a folded line bar made of more than two V-shaped bars, or a wave-shaped bar made of more than two U-shaped bars.
  • the support The rod 130 has two or more head ends 132, such a support rod 130 can attach the filter mesh 120 to the upper wall of the aortic arch at multiple angles, and the support rod 130 has better deployment strength, which can make the frame 110 Better anchoring within the aortic arch.
  • the first line segment V1 may be formed between the first end 131 of the support rod 130 and any head end 132 on the support rod 130.
  • a virtual line segment, the second line segment V2 may be another virtual line segment formed between the second end 131 of the support rod 130 and any head end 132 of the support rod 130 .
  • the lengths of the four support rods 130 in FIG. 1 are different, specifically, they gradually increase from the proximal end to the distal end of the embolic protection device 100 .
  • the four support rods 130 all have a certain degree of bending toward the distal end, and the degree of bending can also be different, as long as they cooperate with each other to ensure that the propped up filter mesh 120 fully fits the upper walls of the three branches of the aortic arch.
  • the value range of the minimum angle b between the support rod 130 and the frame 110 is greater than or equal to 10 degrees and less than or equal to 80 degrees.
  • the four head ends 132 on the embolic protection device 100 are bent downward towards the distal end and slightly towards the direction of the frame 110, so as to prevent the distal ends of the head ends 132 from piercing the filter when entering and leaving the sheath tube 400 120, or poke into the superior wall tissue of the aortic arch during deployment.
  • the head end 132 of each support rod 130 can be blunted.
  • at least one head end 132 is provided with an anti-damage member, such as a ball head formed by hot-melting the head end 132 , silica gel wrapping the head end 132 , etc., so as to prevent the head end 132 from piercing the filter screen 120 .
  • the head end 132 on the support rod 130 may also extend toward the distal end while extending slightly upward toward the direction away from the frame 110. At this time, the head end 132 may adopt the aforementioned passivation treatment or be provided with the aforementioned anti-damage piece, and the head end 132 is the highest point on the support rod 130 where it is located. In other implementations, as shown in FIG.
  • all the head ends 132 are bent downward for a short distance toward the distal end and toward the frame 110 , and the curvature c of the head ends 132 is bent downward in a value range of R2 To R30, so that there is no point at the portion of the support rod 130 in contact with the filter screen 120 , and the support rod 130 is in smooth contact with the filter screen 120 , thereby preventing the head end 132 from piercing the filter screen 120 .
  • the support rod 130 includes two or more head ends 132
  • one or more head ends 132 of the support rod 130 can adopt the above-mentioned method for preventing the head end 132 from piercing the filter screen 120, which is not described here. Let me repeat.
  • the value range of the vertical distance H is greater than or equal to 0 mm and less than or equal to 30 mm, for example, the value of H may be 0 mm, 10 mm, 20 mm or 30 mm. In this embodiment, because the head end 132 is slightly bent downward, the head end 132 is not the highest point on the support rod 130 .
  • the vertical distance H from the highest point on the support rod 130 to the horizontal plane M is greater than 30 millimeters, the height difference between the first end 131 or the second end 131 and the head end 132 of the support rod 130 is too large, and It is unfavorable for the bonding of the support rod 130 as a whole and the filter screen 120 , thereby affecting the sealing performance of the filter screen 120 to the three branches.
  • the vertical distance H from the highest point on the support rod 130 to the horizontal plane M is less than 0 mm, the support height of the support rod 130 is limited, which is not conducive to the fit of the filter mesh 120 to the upper wall of the aortic arch. Assuming that point A on the support rod 130 in FIG. 7 is the highest point, then the vertical distance from point A to the horizontal plane M is H.
  • the vertical projection point B of the head end 132 on the support rod 130 to the horizontal plane M, the vertical projection point C of the first end 131 of the support rod 130 to the horizontal plane M and the vertical projection point of the second end 131 to the horizontal plane M The value range of the vertical distance L1 between the connecting lines CD of D is greater than or equal to 20 mm and less than or equal to 120 mm, for example, the value of L1 may be 30 mm.
  • the shortest distance between the first end 131 and the second end 131 of the support rod 130, that is, the length of the straight line CD, ranges from 20 mm to 100 mm, such as between the first end 131 and the second end 131 The shortest distance can be 50mm.
  • each support rod 130 cooperates with each other to not only fully attach the filter mesh 120 to the three branches 210 of the aortic arch 200, but also to be compatible with the
  • the frame 110 that is squeezed by the inner wall of the aortic arch 200 interacts.
  • the frame 110 transmits a part of the force to each support rod 130 after being squeezed, so that each support rod 130 further supports the filter screen 120 upwards, thereby making the filter screen 120 is more close to the upper wall of the three branches 210 of the aortic arch 200.
  • each support rod 130 reacts against the frame 110, and supports the two sides of the frame 110 connected with each support rod 130 outward, so that the frame 110 It can be stably anchored on the inner wall of the aortic arch 200 .
  • the frame 110 when the embolic protection device 100 is placed on the horizontal plane M, the frame 110 is basically completely attached to the horizontal plane M. As shown in FIG. In another implementation, as shown in FIG. 6 , when the embolic protection device 100 is placed on the horizontal plane M, only the distal portion of the frame 110 is in contact with the horizontal plane M, while the middle portion of the frame 110 is arched upwards, that is, The frame 110 is curved relative to the horizontal plane M, and the value range of the curved curvature d is R20 to R200, so that after the embolic protection device 100 is released, the curved frame 110 can promote the support rod 130 and the filter screen 120 to be more compact. Fits well to the upper wall of the aortic arch 200 .
  • the value range of the axial length L2 of the frame 110 is 50 mm to 150 mm;
  • the widths can be different, and the maximum width W ranges from 30 mm to 100 mm, so that the three branches 210 of the aortic arch 200 can cover most of the anatomical structures to achieve effective anti-embolism.
  • the filter screen 120 is only covered on each support rod 130 without being fixedly connected thereto.
  • a part of the support rod 130 may be partially fixed on the filter mesh 120 by means of glue bonding or suture stitching.
  • one support rod 130 includes two or more head ends 132, it is also possible to prevent the head ends 132 from being hinged when being sheathed.
  • the proximal end of the frame 110 is provided with a connecting piece 140 connected to the distal end of the sheath core 300 .
  • the connector 140 can be made of nickel-titanium alloy.
  • the proximal section 141 of the connector 140 is in a hollow tubular shape, and the distal section 142 is rod-shaped. The distal end of the proximal section 141 and the proximal end of the distal section 142 are connected directly.
  • the proximal section 141 of the connector 140 is used to allow the distal end of the sheath core 300 to pass through the proximal end and pass through the distal end, and then the sheath core 300 extends to the distal end for a certain distance until the distal end of the sheath core 300 The end is more distal than the distal end of the embolic protection device 100 .
  • the distal segment 142 can rest against the sheath core 300 .
  • the embolic protection device 100 can be fixedly connected to the distal end of the sheath core 300 through the proximal section 141 of the connecting member 140 .
  • the embolic protection device 100 may also be fixedly connected to the sheath core 300 through the frame 110 or the support rod 130 .
  • the developing member 150 can be made of a material that can be developed under DSA equipment, such as gold, platinum, platinum-iridium alloy or other materials with strong developability.
  • the specific structure or shape of the developing member 150 is not limited, as long as it can be fixed at a proper position of the embolic protection device 100 .
  • a first developing member 151 may be provided at the distal end of the embolic protection device 100
  • a second developing member 152 may be provided at the proximal end of the embolic protection device 100 .
  • other developing components 150 may also be provided at other positions of the embolic protection device 100, for example, a developing component 150 may be provided on the head end 132 of the support rod 130 in the middle area of the embolic protection device 100, to assist judgment Whether the filter 120 on the embolic protection device 100 is effectively attached to the upper wall of the aortic arch 200 .
  • This embodiment also proposes an embolic protection system comprising the above-mentioned embolic protection device 100 and a sheath core 300 , and the embolic protection system further includes a sheath tube 400 for compressing and delivering the above-mentioned embolic protection device 100 .
  • the above-mentioned embolic protection device 100 has superelasticity and shape memory characteristics. After being fixed to the distal end of the sheath core 300, the embolic protection device 100 is pulled into the sheath tube 400 through the sheath core 300 to be in a compressed state, so as to facilitate the use of the sheath tube. 400 delivers the embolic protection device 100 into the body.
  • the embolic protection device 100 After the embolic protection device 100 protrudes from the sheath tube 400 , it can self-expand and expand under the action of the shape memory property to assume the deployed state as shown in FIG. 1 .
  • the released and deployed shape of the embolic protection device 100 at the aortic arch 200 is generally consistent with the deployed state in the natural state shown in FIG.
  • the above descriptions of the embolic protection device 100 all describe the features in the deployed state unless otherwise specified.
  • the proximal end of the embolic protection device 100 can be fixed on the sheath core 300, and the distal end is not fixed, or the embolic protection device 100 can be The distal end is fixed on the sheath core 300, and the proximal end is not fixed.
  • the following will describe in detail by taking the proximal end of the embolic protection device 100 fixed on the sheath core 300 as an example.
  • the embolic protection device 100 is pulled into the sheath tube 400.
  • the embolic protection device 100 is radially compressed and axially extended to be accommodated inside the distal end of the sheath tube 400 in a compressed state.
  • puncture is performed from the femoral artery on one side of the human body or animal body, and then a guide wire is sent in to establish a delivery channel in the body; after the guide wire reaches a predetermined position, the sheath tube 400 containing the embolic protection device 100 is transported along the guide wire channel To the area where the aortic arch 200 is located, at this time, with the help of DSA equipment, according to the positions of the multiple developing components 150 set on the embolic protection device 100, the relative positions of the embolic protection device 100 and the three branches 210 of the aortic arch 200 are judged, and when the DSA When the device observes that the first developing part 151 and the second developing part 152 on the embolic protection device 100 are located at the two ends of the three branches 210 of the aortic arch 200, keep the sheath core 300 still, and then slowly withdraw the sheath tube 400, To gradually release the embolic protection device 100 from the sheath tube 400 until the entire embolic protection device 100
  • Embodiment 2 proposes another embolic protection device and its embolic protection system.
  • the embolic protection device 500 of Example 2 is generally similar to the embolic protection device 100 of Example 1, the definition and characteristics of the virtual first line segment V1 and the virtual second line segment V2 are also consistent, and the operation process is also generally consistent.
  • the embolic protection device 500 of Embodiment 2 is provided with at least one sliding constraint ring 160, and the sliding constraint ring 160 can be set on the frame 110 or on at least one head end 132 of the support rod 130; implementation
  • the distal end of the sheath core 300 passes through one or more sliding confinement rings 160 on the embolic protection device 500, so that when the embolic protection device 500 is squeezed by the aortic arch 200, the sliding confinement rings 160 can Move axially along the sheath core 300, so that the entire embolic protection device 500 is adaptively bent and deformed to better fit the upper wall of the aortic arch 200 to achieve a more effective anti-embolism effect, and at the same time prevent the embolic protection device 500 from The deviation occurs relative to the sheath core 300, resulting in the inability to effectively filter thrombus and the like.
  • a sliding confinement ring 160 can be provided on at least one head end 132 of one or more support rods 130 of the embolic protection device 500, and the number of the sliding confinement rings 160 on each head end 132 can be set as required.
  • the head end 132 of the most distal support rod 130 of the embolic protection device 500 is provided with a sliding constraint ring 160 , which not only prevents the distal end of the embolic protection device 500 from being biased relative to the sheath core 300
  • the sheath core 300 can also be used to conform to the bending of the aortic arch 200 to promote the support rod 130 to better prop up the filter screen 120, so that the filter screen 130 fits more tightly at the three branches 210, filtering In addition, it can prevent the head end 132 of the support rod 130 from poking into the filter mesh 120 or the inner wall of the aortic arch 200 .
  • a sliding constraint ring 160 may be provided at the distal end or the proximal end of the frame 110 of the embolic protection device 500 .
  • at least one sliding constraining ring 160 may be respectively provided on the distal end of the frame 110 of the embolic protection device 500 and on at least one head end 132 of at least one support rod 130 .
  • the proximal end of the embolic protection device 500 is fixed on the distal end of the sheath core 300, and the distal end is relatively fixed on the sheath core 300 through the sliding confinement ring 160 on the frame 110, and the embolic protection device 500 and the sheath core
  • the distal ends of the sheath tube 400 are received at the distal end of the sheath tube 400 so as to assume a compressed state.
  • the state in which the embolic protection device 100 is accommodated in the sheath tube 400 in the first embodiment is similar to that shown in FIG. 12 .
  • one end of the embolic protection device 500 needs to be fixed at a suitable position at the distal end of the sheath core 300, the proximal end of the embolic protection device 500 can be fixed on the sheath core 300, and the distal end passes through the sheath through the set sliding constraint ring 160
  • the distal end of the core 300 is relatively fixed, and the distal end of the embolic protection device 500 can also be fixed on the sheath core 300 , and the proximal end is relatively fixed through the distal end of the sheath core 300 through the provided sliding constraint ring 160 .
  • the proximal end of the embolic protection device 500 is fixed on the distal end of the sheath core 300 , and the distal end passes through the distal end of the sheath core 300 through the sliding constraint ring 160 on the frame 110 for relative fixation.
  • the operation process is generally consistent with that of Example 1, and will not be repeated here.
  • the sliding constraining ring 160 on the embolic protection device 500 makes the embolic protection device 500 always slide along the axial direction of the sheath core 300 during release, deployment and recovery, and can well conform to the curved shape of the aortic arch 200 to further reduce embolic protection. There is a risk of excessive twisting or deflection of the device 500 .
  • Embodiment 3 proposes another embolic protection device and its embolic protection system.
  • the embolic protection device 600 of the third embodiment is generally similar to the embolic protection device 100 of the first embodiment, and the operation process is also generally the same. The main difference between the two is that the distal end section 142 of the connecting piece 140 of the embolic protection device 600 of the third embodiment is rotationally connected with the proximal end of the frame 110.
  • the sheath core then extends to the distal end for a certain distance until the sheath core
  • the distal end of the embolic protection device 600 is closer to the distal end than the distal end of the embolic protection device 600.
  • the embolic protection device 600 can be fixed at the aortic arch to prevent thrombus from entering the blood vessels of the brain and prevent stroke and other symptoms.
  • the embolic protection device 600 is spliced with the sheath core, which can be pushed out or put into the sheath by pushing and pulling the sheath core.
  • the embolic protection device 600 When the embolic protection device 600 is released in the aortic arch, due to the extrusion and friction of the blood vessel wall, the embolic protection device 600 often occurs. If it cannot be fully expanded, the frame 110 will be bent, which may lead to the risk that the embolic protection device 600 cannot cover the blood vessels in the brain and affect the performance of the device.
  • the distal section 142 of the connector 140 of the embolic protection device 600 is rotationally connected to the proximal end of the frame 110, so that the connector 140 of the embolic protection device 600 has better deformation ability, and is subjected to extrusion energy when released. Provide a space for the embolic protection device 600 so that it can fully expand, thereby avoiding bending of the frame 110 .
  • At least one connecting hole 111 is opened at the proximal end of the frame 110, and the distal end section 142 of the connecting piece 140 passes through the connecting hole 111 and is fixed on the connecting piece. 140 , specifically, it can be fixed on the distal end section 142 itself, so that the connecting piece 140 is rotatably connected to the frame 110 .
  • the distal end section 142 can be fixed by welding, riveting, stamping or glue after passing through the connecting hole 111, or can be fixed by braiding and winding on the distal end section 142 itself, which is not specifically limited in the embodiment of the present invention.
  • a welding point can be arranged on the distal end section 142, the width of the welding point is greater than the width of the distal end section 142, and the distal end section 142 can be welded on the welding spot after passing through the connecting hole 111. At the point, the welding joint area can be increased to ensure the strength of the welding.
  • the proximal end of the frame 110 can be provided with two connection holes 111, the distal section 142 of the connecting piece 140 is cut into two bifurcated sections, and the two bifurcated sections
  • the fork segments pass through the two connection holes 111 respectively and are fixed at the fork of the distal end segment 142 .
  • the proximal end of the frame 110 can be provided with two connecting holes 111, and the distal section 142 of the connecting piece 140 is cut into two bifurcated sections, two The bifurcated section passes through two connection holes 111 and is fixed on the bifurcation section itself, wherein the diameter of the surrounding hole formed by the bifurcated section through the connection hole 111 is slightly greater than the distance from the connection hole 111 to the edge of the frame 110 to ensure The embolic protection device 600 has certain mobility.
  • a connecting hole 111 may be opened at the proximal end of the frame 110, and the distal end section 142 of the connecting piece 140 passes through the connecting hole 111 and then is braided and wound for a certain length.
  • a metal wire with a suitable diameter is passed through the connecting hole 111 and then braided and wound for a certain length before being welded on the distal end section 142 of the connecting member 140 .
  • the metal wire may be Nitinol wire.
  • At least one sliding confinement ring 160 can be provided on the embolic protection device 600 , and the sliding confinement ring 160 can be provided on the frame 110 or on the side of the support rod 130 At least one head end 132, so that when the embolic protection device 600 is squeezed by the aortic arch, the sliding constraint ring 160 can move axially along the sheath core, so that the entire embolic protection device 600 can be adaptively bent and deformed to better Fitting the upper wall of the aortic arch achieves a more effective anti-embolism effect, and at the same time prevents the embolic protection device 600 from shifting relative to the sheath core, resulting in failure to effectively filter thrombus and the like.
  • the specific setting method refer to Embodiment 2, and the embodiment of the present invention will not be described in detail here.
  • Embodiment 4 proposes another embolic protection device and its embolic protection system.
  • the embolic protection device 700 of Embodiment 4 is generally similar to the embolic protection device 600 of Embodiment 3, and its structure and function are generally the same.
  • the distal section 142 of the connector 140 is also connected to the proximal end of the frame 110 by rotation, and the operation process is also generally the same. .
  • the main difference between the two is that the connection part 140 of the embolic protection device 700 is connected with the frame 110 through the universal ball device 170 .
  • the universal ball device 170 includes a ball seat 171 and a rotatable ball 172 placed in the ball seat 171, the ball seat 171 includes a groove, and the distance from the notch of the groove to the bottom of the groove is Greater than the radius of the ball 172 , the distance from the notch of the groove to the bottom of the groove is smaller than the diameter of the ball 172 , so that the ball 172 can rotate freely in the ball seat 171 without breaking away from the ball seat 171 .
  • one of the ball seat 171 and the ball 172 is connected with the distal section 142 of the connecting member 140 , and the other is connected with the proximal end of the frame 110 .
  • the ball seat 171 or the ball 172 connected to the frame 110 may be directly connected to the frame 110 or indirectly connected to the frame 110 through a connecting rod.
  • the connecting rod can be a nickel-titanium alloy rod.
  • Embodiment 5 proposes another embolic protection device and its embolic protection system.
  • the embolic protection device 800 of Embodiment 5 is generally similar to the embolic protection device 700 of Embodiment 4, and its structure and function are generally the same.
  • the distal section 142 of the connector 140 is also connected to the proximal end of the frame 110 by rotation, and the operation process is also generally the same. .
  • the main difference between the two is that the connection part 140 of the embolic protection device 800 is connected to the frame 110 through the hinge device 180 .
  • the hinge device 180 is a rotating shaft structure, including a first rotating member 181 and a second rotating member 182, the first rotating member 181 and the second rotating member 182 are coaxially rotatably connected, wherein the first rotating member 181 One of the first rotating member 181 and the second rotating member 182 is connected to the distal end section 142 of the connecting member 140 , and the other is connected to the proximal end of the frame 110 .
  • the first rotating member 181 or the second rotating member 182 connected to the frame 110 may be directly connected to the frame 110 or indirectly connected to the frame 110 through a connecting rod.
  • the connecting rod can be a nickel-titanium alloy rod.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif de protection embolique (100), comprenant un cadre (110), un tamis de filtre de bord (120), et une pluralité de tiges de support (130) qui sont agencées à intervalles. Chaque tige de support (130) comprend une première extrémité de queue (131), une seconde extrémité de queue (131) et au moins une extrémité de tête (132) qui fait face à une extrémité distale. La première extrémité de queue (131) et la seconde extrémité de queue (131) sont respectivement reliées à deux côtés opposés du cadre (110). La première extrémité de queue (131) et la seconde extrémité de queue (131) forment respectivement un premier segment de ligne (V1) et un second segment de ligne (V2) avec l'extrémité de tête (132). Le premier segment de ligne (V1) s'étend dans une direction allant de la première extrémité de queue (131) à l'extrémité de tête (132) et s'écarte progressivement du cadre (110), et le second segment de ligne (V2) s'étend dans une direction allant la seconde extrémité de queue (131) à l'extrémité de tête (132) et s'écarte progressivement du cadre (110), de telle sorte que la pluralité de tiges de support (130) supportent le tamis de filtre de bord (120), qui recouvre la pluralité de tiges de support (130), dans une direction opposée au cadre (110). Le dispositif peut fixer le tamis de filtre de bord à trois branches d'un arc de l'aorte sans l'aide d'une gaine-noyau. De plus, lors d'une application pratique, le cadre et les tiges de support interagissent et se renforcent mutuellement, de sorte que la fixation stable du cadre à l'arc de l'aorte est facilitée, et les tiges de support fournissent une force de support vers le haut plus grande pour le tamis de filtre, ce qui permet de mieux fixer le tamis de filtre de bord à l'arc de l'aorte.
PCT/CN2022/092218 2021-05-13 2022-05-11 Dispositif de protection embolique WO2022237836A1 (fr)

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EP22806798.9A EP4338704A1 (fr) 2021-05-13 2022-05-11 Dispositif de protection embolique
CN202280003954.0A CN115916111A (zh) 2021-05-13 2022-05-11 栓塞保护装置

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CN202110521963 2021-05-13

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140031857A1 (en) * 2012-07-25 2014-01-30 Boston Scientific Scimed, Inc. Embolic protection filter for transcatheter aortic valve replacement and uses thereof
CN109640880A (zh) * 2017-05-12 2019-04-16 企斯动哈特有限公司 用于过滤血管系统中栓塞材料的装置
CN110167484A (zh) * 2017-10-27 2019-08-23 企斯动哈特有限公司 圆顶形过滤装置及其制造方法
CN211325886U (zh) * 2019-11-28 2020-08-25 上海微创医疗器械（集团）有限公司 一种血栓阻隔装置
CN214632500U (zh) * 2020-11-05 2021-11-09 上海微盾医疗科技有限公司 抗栓塞保护装置及医疗器械
CN114431998A (zh) * 2020-11-05 2022-05-06 上海微盾医疗科技有限公司 抗栓塞保护装置及医疗器械

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140031857A1 (en) * 2012-07-25 2014-01-30 Boston Scientific Scimed, Inc. Embolic protection filter for transcatheter aortic valve replacement and uses thereof
CN109640880A (zh) * 2017-05-12 2019-04-16 企斯动哈特有限公司 用于过滤血管系统中栓塞材料的装置
CN110167484A (zh) * 2017-10-27 2019-08-23 企斯动哈特有限公司 圆顶形过滤装置及其制造方法
CN211325886U (zh) * 2019-11-28 2020-08-25 上海微创医疗器械（集团）有限公司 一种血栓阻隔装置
CN214632500U (zh) * 2020-11-05 2021-11-09 上海微盾医疗科技有限公司 抗栓塞保护装置及医疗器械
CN114431998A (zh) * 2020-11-05 2022-05-06 上海微盾医疗科技有限公司 抗栓塞保护装置及医疗器械

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CN115916111A (zh) 2023-04-04

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